Liquid, Aqueous Pharmaceutical Composition of Factor VII Polypeptides
a technology of factor vii and aqueous pharmaceutical composition, which is applied in the direction of peptide/protein ingredients, inorganic non-active ingredients, extracellular fluid disorder, etc., can solve the problems of reducing activity, increasing immunogenicity, and lowering activity, so as to improve stability
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Example 1
[0132]Effect of addition of copper-containing and manganese-containing agents to aqueous rFVIIa solutions on heavy chain degradation (autocatalytic cleavage)
[0133]In order to investigate the effect of metal ions on rFVIIa, the following procedure was followed:
[0134]rFVIIa was transferred to the following solutions by desalting on a PD-10 column (Amersham Biosciences):
rFVIIa1.0mg / mLSodium chloride2.92mg / mL (50 mM)Calcium chloride 2 H2O1.47mg / mL (10 mM)PIPES15.12mg / mL (50 mM)1 M NaOHadded to pH 6.5
[0135]Two solutions of metal-containing agents were prepared:
Copper(II) chloride, 2 H2O10 mMManganese chloride, 2 H2O 2 M
[0136]The copper-containing and manganese-containing agents, respectively, were added to the desalted rFVIIa solution in order to reach the concentrations outlined in Table 1. pH vas adjusted to 6.5. The formulations were stored at a temperature of 5° C. and analyses were performed at the times indicated in Table 1.
TABLE 1Content of Heavy chain degradation product...
example 2
[0140]Addition of copper-containing and manganese-containing agents and to aqueous rFVIIa solutions at high ionic strength
[0141]In order to investigate the effect of metal ions and high ionic strength on the stability of rFVIIa, the following procedure can be followed:
[0142]rFVIIa is transferred to the following solutions by desalting on a PD-10 column (Amersham Biosciences):
Sodium chloride2.92mg / mL (50 mM)Calcium chloride 2 H2O29.4mg / mL (200 mM)PIPES15.12mg / mL (50 mM)Poloxamer 1881.0mg / mLMethionine0.5mg / mL1 M NaOH / 1 M HCladded to pH 6.5and / orSodium chloride29.2mg / mL (500 mM)Calcium chloride 2 H2O1.47mg / mL (10 mM)PIPES15.12mg / mL (50 mM)Poloxamer 1881.0mg / mLMethionine0.5mg / mL1 M NaOH / 1 M HCladded to pH 6.5
[0143]In both solutions the concentration of Factor VIIa (rFVIIa) is 1.0 mg / mL
[0144]Two solutions of metal-containing agents are prepared:
Copper(II) chloride, 2H2O10 mMManganese chloride, 2 H2O 2 M
[0145]The copper-containing and manganese-containing agents, respectively, are added t...
example 3
[0147]Addition of copper-containing agents to aqueous rFVIIa solutions with high ionic strength.
[0148]In order to investigate the possible synergistic effect of metal ions and high ionic strength on the stability of rFVIIa, the following procedure was followed:
[0149]rFVIIa was transferred into various solutions (formulations) as listed in table 1 below in a two step process:
[0150]First, rFVIIa was transferred into the various solutions without copper added by desalting on a PD-10 column (Amersham Biosciences). Next, the copper content was obtained in solution 2 and 4 by adding a solution of 10 mM Copper(II) chloride, 2H2O until the stated concentration was reached.
[0151]After the copper solution had been added, pH was adjusted to 6.5 and the formulations were filled in cartridges.
[0152]The cartridges were stored at a temperature of 5° C. and analyses were performed after 0, 0.5, 1, 2, and 3 months as indicated in table 2.
TABLE 1FormulationsFormulations1234rFVIIa1.0mg / ml1.0mg / ml1.0mg...
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